Midline Catheter Placement Device

ABSTRACT

A catheter insertion device is provided for positioning and inserting a catheter, particularly a midline catheter into a patient. The insertion device includes an actuator assembly movable with respect to a housing for deploying the catheter over a needle. A step-wise movement of the actuator advances a catheter assembly, including the catheter, in stages over the introducer needle. An indexing finger of the catheter assembly engages the actuator body during distal advancement of the actuator, and deflects as the actuator is moved proximally. The device further includes a lockout device such as a button, collar, slider, or tab, which allows movement of the catheter relative to the needle but prevents advancement of the catheter to the first stage of the step-wise movement.

PRIORITY

This application is a division of U.S. patent application Ser. No.16/996,769, filed Aug. 18, 2020, now U.S. Pat. No. 11,559,665, whichclaims the benefit of priority to U.S. Provisional Application No.62/888,946, filed Aug. 19, 2019, each of which is incorporated byreference in its entirety into this application.

BACKGROUND

Midline catheters are generally used for parenteral nutrition,intravenous (“IV”) fluid replacement and the administration ofanalgesics and antibiotics. Midline catheters are inserted at thebedside using sterile techniques and can remain in place for severalweeks. The insertion (venipuncture) can be performed above and below theantecubital fossa in the cephalic, basilic, or brachial veins. Thecatheter tip is advanced 3 inches to 8 inches with the tip terminatingbelow the axilla and proximal central veins.

The potential advantages of a midline catheter are the reduced frequencyof repeated venipunctures for labs/restarts, decreased incidence ofcatheter related infections, extended implant/indwell duration, improvedclinical outcomes, patient satisfaction and associated cost savings.Placing the catheter tip in the larger diameter veins in the upper armcompared to the smaller veins provide improved drug delivery therapy andhemodilution. Midline catheters can be used for infusing contrast mediaat higher flow rates that are typically done by central venous (“CV”)catheters such as peripherally inserted central venous catheter (“PICC”)applications.

Prior midline catheter devices typically include an integral guidewire.The guidewire is advanced through the lumen of the needle and into thevein after the needle accesses the vein. Often an ultrasonic probe orimaging device is used to locate the needle in the desired location. Thecatheter is then advanced over the guidewire into the vein. The needleand guidewire are then detached and separated from the catheter whichremains in place in the vein.

These prior devices generally require the guidewire to be fully deployedby moving a sliding member into a locked/detent position. To advance thecatheter, the user must put down the ultrasonic probe and use both handsto advance the catheter and complete the final steps of the procedure.This results in a loss of the visualization of the vein and the locationof the catheter relative to the vein.

Catheter placement and advancement is dependent on holding the device ina stationary position with one hand while manipulating the catheteradvancing mechanism in the other hand without the use of the ultrasonicimaging to assist in proper placement of the catheter. Once the catheteris fully advanced, the user must re-position the ultrasonic probe tore-establish the image and confirm proper placement of the catheter. Theoperation requires a series of sequential steps with specializedtraining. The additional exchange of hand positions from the ultrasonicprobe to the device and back to the probe adds complexity to theprocedure and risks the success of the proper placement of the catheter.

What is needed, therefore is a catheter placement device thatstreamlines the steps involved in catheter placement, as well as beingoperated with a single hand, while still providing the samefunctionality of current catheter placement devices.

SUMMARY

Briefly summarized, embodiments disclosed herein are directed toextended dwell peripheral IV catheter (“PIVC”) devices that provide alonger length “mini-midline” catheter. The catheter would be placedsimilarly to a PIVC, without the need for a guidewire and would onlyrequire one-handed operation. Placement would be carried out underultrasound imaging guidance and can access deeper vessels or facilitatedifficult venous access (“DVA”) procedures. The catheter would be ableto successfully extend the dwell time for patients requiring medium/longterm IV therapy, for example between 5 and 30 days.

Disclosed herein is a catheter placement device including, a housing, aneedle extending from a distal end of the housing, a catheter assemblydisposed coaxially over the needle, including a catheter supported by acatheter hub, and a safety assembly including a first indexing finger,and an actuator assembly configured to transition longitudinally betweena first position and a second position, the actuator assembly including,an actuator button extending through an elongate opening in the housing,and an actuator body including a plurality of actuator abutments,wherein the first indexing finger engages a first actuator abutment ofthe plurality of actuator abutments and the actuator assembly distallyadvances the catheter assembly in a stepwise manner as the actuatorassembly moves between the first position and the second position.

In some embodiments, the first indexing finger is integrally molded withthe safety assembly to form a single structure, the first indexingfinger configured to flexibly deform as the actuator body moves from thesecond position to the first position. The first indexing finger issupported by a collar and is formed as a separate structure from thesafety assembly, the collar being coupled to the safety assembly, andthe first indexing finger configured to flexibly deform as the actuatorbody moves from the second position to the first position. The housingincludes a plurality of housing tabs that engage the safety assembly toprevent proximal movement thereof. The housing includes a plurality ofhousing abutments that engage a second indexing finger extending fromthe safety assembly to prevent proximal movement thereof.

In some embodiments, the actuator body includes a top wall, a first sidewall, and a second side wall that define an inverse channel throughwhich the catheter assembly moves along a longitudinal axis. One of thefirst side wall or the second side wall includes a plurality of notchesthat define the plurality of actuator abutments. One of the first sidewall or the second side wall includes a plurality of apertures thatdefine the plurality of actuator abutments. The housing includes a firstdoor and a second door disposed at a distal end thereof and configuredto pivot through a horizontal plane between an open position and aclosed position. The housing includes a first housing half and a secondhousing half joined along a longitudinally vertical plane, the firstdoor hingedly coupled to the first housing half and the second doorhingedly coupled to the second housing half.

In some embodiments, the housing includes a first hinged door disposedat a distal end thereof and configured to pivot through a verticalplane. The housing includes a first housing half and a second housinghalf joined along a longitudinally horizontal plane, the first doorhingedly coupled to the first housing half. In some embodiments, thecatheter placement device further includes a lockout device thattransitions between a locked position and an unlocked position, thelocked position allowing a movement of the catheter relative to theneedle and restricting distal advancement of the catheter assembly inthe stepwise manner. The movement of the catheter relative to the needleis restricted to less than a longitudinal distance between the firstactuator abutment and a second actuator abutment, adjacent to the firstactuator abutment. The movement of the catheter relative to the needleis restricted to less than half a longitudinal distance between thefirst actuator abutment and a second actuator abutment, adjacent to thefirst actuator abutment. The movement of the catheter relative to theneedle is restricted to a distance of between 1 mm to 3 mm.

In some embodiments, the lockout device includes a lockout buttonincluding an engagement arm having a first aperture defining a firstdiameter, and a second aperture defining a second diameter, the seconddiameter being larger than the first diameter, the first aperturecommunicating with the second aperture to define a keyhole shape thatreceives an anchor portion of the safety assembly therethrough. Thelockout button transitions between the locked position and an unlockedposition, the anchor portion is disposed within the first aperture inthe locked position and the second aperture in the unlocked position.The anchor portion includes a flange that extends radially from aproximal end of the anchor portion, the flange defining a diameter thatis larger than the first diameter and smaller than the second diameter,the flange abuts against the engagement arm when the lockout button isin the locked position.

In some embodiments, the lockout device includes a lockout collarslidably engaged with an outer surface of the housing and transitionslongitudinally between the locked position and the unlocked position.The lockout collar encircles a longitudinal axis of the housing, thelockout collar covering a portion of the elongate opening in the lockedposition to restrict movement of the actuator assembly. The lockoutcollar is disposed between the actuator button and a first protrusion inthe locked position, and between the first protrusion and a secondprotrusion in the unlocked position. The lockout device includes alockout slider disposed on the actuator button and slides perpendicularto a longitudinal axis to engage a notch, when in the locked position. Alongitudinal width of the slider is less than a longitudinal width ofthe notch to allow movement of the actuator button in the lockedposition and restrict distal advancement of the catheter assembly in thestepwise manner.

In some embodiments, the lockout slider in the unlocked position alignswith the actuator button to disengage the notch and allow the actuatorassembly to move between the first position and the second position. Thelockout device includes a lockout tab interposed between the actuatorassembly and the housing in the locked position, which restrictsmovement of the actuator assembly. The lockout tab extends through aslot in the housing, the tab defining a longitudinal width that is lessthan a longitudinal length of the slot.

Also disclosed is a method of inserting a catheter including, providinga catheter insertion device having a housing, a needle extending from adistal end of the housing, an actuator assembly including an actuatorbutton and an actuator body, a catheter assembly disposed coaxially overthe needle having, a catheter supported by a catheter hub and a safetyassembly, and a lockout device transitionable between a locked positionand an unlocked position, the locked position permitting movement of thecatheter relative to the needle and inhibiting advancement of thecatheter in a stepwise manner, actuating the actuator button with thelockout device in the locked position to move the catheter relative tothe needle, transitioning the lockout device from the locked position tothe unlocked position, inserting the needle into a patient to access avasculature thereof, and actuating the actuator button from a firstposition to a second position to advance the catheter in the stepwisemanner relative to the needle.

In some embodiments, the actuator body includes a plurality of actuatorabutments, and the safety assembly includes an indexing finger, theindexing finger engaging an actuator abutment of the plurality ofactuator abutments as the actuator button moves from the first positionto the second position, and the indexing finger deflecting as theactuator button moves from the second position to the first position.

Also disclosed is a method of advancing a catheter over a needleincluding, providing a catheter placement device having a housingincluding a plurality of housing tabs and a needle extending from adistal end thereof. The catheter placement device further having acatheter assembly including a catheter disposed coaxially over theneedle and engaging a first housing tab of the plurality of housingtabs, an actuator assembly configured to move between a first positionand a second position to advance the catheter assembly from the firsthousing tab to a second housing tab adjacent to the first housing tab,and a lockout device transitionable between a locked position and anunlocked position. The locked position restricts movement of thecatheter assembly between the first housing tab and the second housingtab, and the unlocked position permits movement of the catheter assemblybetween the first housing tab and the second housing tab. The methodfurther includes actuating the actuator button with the lockout devicein the locked position to move the catheter relative to the needle whilepreventing the catheter assembly from advancing from the first housingtab to the second housing tab, transitioning the lockout device from thelocked position to the unlocked position, inserting the needle into apatient to access a vasculature thereof, and actuating the actuatorbutton from the first position to the second position to advance thecatheter assembly from the first housing tab to the second housing tab.

In some embodiments, the lockout device is one of a lockout button, alockout collar, a lockout slider and a lockout tab. The housing includesa first hinged door and a second hinged door, each disposed at thedistal end of the housing and configured to pivot to an open position torelease the catheter hub.

DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 shows a perspective view of a catheter insertion device showingthe actuator in a starting position, in accordance with embodimentsdisclosed herein.

FIG. 2 shows a perspective view of the catheter insertion device of FIG.1 showing the actuator in the forward actuated position, in accordancewith embodiments disclosed herein.

FIG. 3 shows a cutaway side view of the catheter insertion device ofFIG. 1 showing the catheter and hub in the starting position, and withthe introducer needle extending from the distal end of the catheterinsertion device, in accordance with embodiments disclosed herein.

FIGS. 4A-4B show perspective exploded views of the catheter hub andsafety assembly separated from the housing of a catheter insertiondevice, in accordance with embodiments disclosed herein.

FIG. 5A shows a cutaway side view of a catheter insertion device showingthe catheter and hub in the starting position, and with the introducerneedle extending from the distal end of the catheter insertion device,in accordance with embodiments disclosed herein.

FIGS. 5B-5E show various views of a catheter hub and safety assembly, inaccordance with embodiments disclosed herein.

FIG. 6A shows a perspective cutaway view of a proximal portion of acatheter insertion device, in accordance with embodiments disclosedherein.

FIG. 6B shows a close up view of the catheter insertion device of FIG.6A, in accordance with embodiments disclosed herein.

FIGS. 6C-6D show cutaway side views of the catheter insertion device ofFIG. 6A, in accordance with embodiments disclosed herein.

FIG. 7A shows a perspective cutaway view of a catheter insertion deviceincluding a lockout device, in accordance with embodiments disclosedherein.

FIG. 7B shows a proximal end view of the lockout device of FIG. 7A, inaccordance with embodiments disclosed herein.

FIGS. 8A-8D show various views of a catheter insertion device includinga lockout device, in accordance with embodiments disclosed herein.

FIGS. 9A-9C show various views of a catheter insertion device includinga lockout device, in accordance with embodiments disclosed herein.

FIGS. 10A-10D show various views of a catheter insertion deviceincluding a lockout device, in accordance with embodiments disclosedherein.

DESCRIPTION

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

Regarding terms used herein, it should also be understood the terms arefor the purpose of describing some particular embodiments, and the termsdo not limit the scope of the concepts provided herein. Ordinal numbers(e.g., first, second, third, etc.) are generally used to distinguish oridentify different features or steps in a group of features or steps,and do not supply a serial or numerical limitation. For example,“first,” “second,” and “third” features or steps need not necessarilyappear in that order, and the particular embodiments including suchfeatures or steps need not necessarily be limited to the three featuresor steps. Labels such as “left,” “right,” “top,” “bottom,” “front,”“back,” and the like are used for convenience and are not intended toimply, for example, any particular fixed location, orientation, ordirection. Instead, such labels are used to reflect, for example,relative location, orientation, or directions. Singular forms of “a,”“an,” and “the” include plural references unless the context clearlydictates otherwise.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a user using the device to be describedherein, while the word “distal” refers to a direction relatively furtherfrom the user. For example, with respect to “proximal,” a “proximalportion” or a “proximal end portion” of, for example, a catheterdisclosed herein includes a portion of the catheter intended to be neara user when the catheter is used on a patient. Likewise, a “proximallength” of, for example, the catheter includes a length of the catheterintended to be near the user when the catheter is used on the patient. A“proximal end” of, for example, the catheter includes an end of thecatheter intended to be near the user when the catheter is used on thepatient. The proximal portion, the proximal end portion, or the proximallength of the catheter can include the proximal end of the catheter;however, the proximal portion, the proximal end portion, or the proximallength of the catheter need not include the proximal end of thecatheter. That is, unless context suggests otherwise, the proximalportion, the proximal end portion, or the proximal length of thecatheter is not a terminal portion or terminal length of the catheter.

With respect to “distal,” a “distal portion” or a “distal end portion”of, for example, a catheter disclosed herein includes a portion of thecatheter intended to be near or in a patient when the catheter is usedon the patient. Likewise, a “distal length” of, for example, thecatheter includes a length of the catheter intended to be near or in thepatient when the catheter is used on the patient. A “distal end” of, forexample, the catheter includes an end of the catheter intended to benear or in the patient when the catheter is used on the patient. Thedistal portion, the distal end portion, or the distal length of thecatheter can include the distal end of the catheter; however, the distalportion, the distal end portion, or the distal length of the catheterneed not include the distal end of the catheter. That is, unless contextsuggests otherwise, the distal portion, the distal end portion, or thedistal length of the catheter is not a terminal portion or terminallength of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

The terms “needle” and “cannula” can be used herein interchangeably torefer to a member having a sharpened or beveled end for insertion intoan injection site on a subject. In one embodiment, the needle can be athin hollow tubular member.

As used herein, and as shown in FIG. 4A, the longitudinal axis extendsparallel to an axial length of the catheter, a lateral axis extendsnormal to the longitudinal axis, and a transverse axis extends normal toboth the longitudinal and lateral axes. As used herein, the “axial”means along or parallel to the longitudinal axis of the needle and the“radial” direction is a direction perpendicular to the axial direction.The forward direction is the direction toward the distal end of thedevice. The backward direction is the direction toward the proximal endof the device. Unless defined otherwise, all technical and scientificterms used herein have the same meaning as commonly understood by thoseof ordinary skill in the art.

Embodiments disclosed herein are directed to a catheter placementdevice, also termed “catheter insertion device,” with a streamlinedoperation and the ability to be placed with a single hand, allowing auser to also operate an ultrasound probe, or the like, to maintainvisualization.

In reference to FIGS. 1-3 , the catheter insertion device 10 generallyincludes a main body or housing 12, a catheter assembly, including acatheter 14 having a catheter hub 16 and a safety assembly 46, anintroducer needle 18, and an actuator assembly 20. The actuator assembly20 forms a shuttling or indexing assembly and mechanism to index andadvance the catheter 14 over the end of the needle 18 in a stepwisemanner by cycling through a plurality of stages. Each stage consistingof moving the actuator assembly 20 from a first position to a secondposition and back to the first position to advance the catheter assemblya given distance in a distal direction.

The housing 12 of the insertion device 10 has a longitudinal dimensionwith a distal end 22 and a proximal end 24. In an embodiment, thehousing 12 can be formed from two housing halves that are joinedtogether by a suitable attachment mechanism. For example, a firsthousing half and a second housing half can be aligned by one or morepins (not shown) protruding from a first housing half, which cancorrespond with one or more recesses 13 on a second housing half (FIG. 3). However, other configurations of pins and recesses, or similarattachment mechanisms including clips, lugs, notches, protrusions,combinations thereof, or the like are also contemplated. The housing 12has a dimension for supporting the introducer needle 18 and catheter 14during use and to enable the user to manipulate the device inpositioning the catheter. Also shown in FIG. 3 , the introducer needle18 is hollow and has a proximal end fixed within an interior cavity 50of the housing 12 by a post 54 or other support. The needle 18 extendsfrom a distal end of the housing 12 through the opening 40 to a pointthat is distal of the distal end 22 of the housing 12.

The housing 12 can define an interior cavity 50 forming a longitudinalpassage. In an embodiment, the housing 12 has curved side walls 26, aflat top wall 28 and a flat bottom wall 30. The flat bottom wall 30 isgenerally provided to allow the device to be placed on a flat surface ina stable position with reduced risk of falling off the surface. It willbe appreciated that the shape of the device 10 can vary withoutlimitation depending on the particular use to provide comfortable andconvenient use by the operator.

In an embodiment, an elongated opening 32 is formed in the top wall 28for receiving a portion of the actuator assembly 20 therethrough. Thehousing 12 can further include a tip portion (“tip”) 34 havingconverging sides that defines the distal end 22 of the housing 12. Asshown in FIG. 4A, two hinged doors 36 of tip 34 are hingedly connectedto the walls 26 by a respective hinge 38. The hinged doors 36 cantransition between a closed position (FIG. 1 ) and an open position(FIG. 4A) to access the interior cavity 50 of the housing 12 and allowremoval of the catheter 14, catheter hub 16, safety assembly 46, orcombinations thereof, from the housing 12. An outlet opening 40 in tip34 enables the catheter 14 and introducer needle 18 to extend from thedistal end of the housing 12 when the hinged doors 36 are in the closedconfiguration. The converging surfaces of tip 34 enable the device to bepositioned at a low angle with respect to the skin of the patient toassist in inserting the catheter 14 and introducer needle 18 into thepatient with reduced risk of kinking or folding of the catheter 14.

Further details of the catheter insertion device 10 can be found inInternational Patent Publication WO 2018/170349, which is incorporatedby reference in its entirety into this application.

As shown in FIGS. 3-4B, in an embodiment, the actuator assembly 20 thatforms the shuttling or indexing assembly, advances a catheter assembly,which includes the catheter 14, catheter hub 16, safety assembly 46, orcombinations thereof, in a distal direction and in a stepwise mannerthrough a series of stages. Each stage comprising of a back and aforward movement of the actuator assembly 20. A forward movement of theactuator assembly 20 causes an actuator tab 76 to engage a portion ofthe catheter assembly and urge the catheter assembly in a distaldirection. At the completion of each forward stroke, the button 68 ispulled back and an adjacent tab 76 of the actuator body 66 is readiedfor the next forward stroke, by engaging the portion of the catheterassembly. As shown in FIG. 3 , the housing can include a plurality offlexible tabs (“housing tabs”) 60. Each tab of the housing tabs 60 canbe configured to deflect to allow the catheter assembly, or portionthereof, to pass distally. Once the catheter assembly has advanceddistally of a deflected tab 60, the tab 60 can return to the undeflectedconfiguration. With each backward stroke, a housing tab 60 can engagethe body 47 of the needle safety assembly 46 to prevent proximalmovement of the catheter assembly. As shown, the starting position ofthe device 10 can be a retracted position (FIG. 1 ). However it will beappreciated that the starting position may also be an extended position(FIG. 2 ), the actuator assembly 20 can then be cycled through thebackward and forward movement of each stage to advance the catheterassembly forward to a distal end of the housing 12.

Once the safety assembly body 47 and catheter hub 16 are advanced to aforward position, proximate a distal end 22 of housing 12, the hingeddoors 36 are pivoted to the open position as shown in FIG. 4A to releasecatheter hub 16 and safety assembly 46, from the housing 12. In anembodiment, the doors 36 can transition to the open position by rotatingthrough a longitudinally horizontal plane, as shown in FIG. 4A. Thecatheter hub 16 is advanced to contact cam surfaces 81 on the innersurface of the doors 36 to transition the doors 36 to the open position.The housing 12 can then be withdrawn proximally from catheter hub 16 towithdraw introducer needle 18 from catheter 14. The safety assembly body47 slides over the distal end 56 of the introducer needle 18 to enclosethe sharp tip and prevent an accidental needle stick injuries. Thecatheter hub 16 is released and separated from safety assembly 46 whenthe body 47 of safety assembly 46 is actuated by the withdrawing ofintroducer needle 18. Housing 12, with the attached introducer needle 18and safety assembly body 47 can then be discarded. Optionally a sealforms a valve that closes a proximal end of the catheter hub 16 tocontrol blood backflow and to allow attachment of an extension set orother devices.

As shown in FIG. 4B, in an embodiment, a first hinged door 36A can behingedly coupled with a top wall 28 and a second hinged door 36B can behingedly coupled with a bottom wall 30. As such, one of the first hingeddoor 36A or second hinged door 36B transitions to the open position byrotating through a longitudinally vertical plane, as shown in FIG. 4B.In an embodiment, a first door 36A can be hingedly coupled to thehousing 12 and a second door 36B can be coupled to the housing 12 in afixed relationship relative to the housing 12, e.g. attached thereto byadhesive, bonding, welding, etc. Advantageously, the second door 36configured as such can provide a supporting structure for the needle 18at the outlet opening 40 of tip 34. In an embodiment, the second door36B is formed as integrally molded with the housing 12 to form a singlestructure. In an embodiment, the first door 36A can be coupled in afixed relationship relative to the housing 12 and the second door 36Bcan be hinged coupled to the housing 12.

Advantageously, the hinging mechanisms of the doors 36 can simplifyfabrication and/or assembly of the catheter insertion device 10 byfollowing the bi-lateral symmetry of the device construction. Forexample, as shown in FIG. 4A, where the housing 12 is formed from twohousing halves that are joined together along a longitudinally verticalplane, the hinged doors 36 can be coupled with the side walls 26.Similarly, as shown in FIG. 4B, where the housing 12 is formed byjoining two halves along a longitudinally horizontal plane, the hingeddoors 36 can be coupled with the top and bottom walls 28, 30 tofacilitate fabrication and assembly.

As shown in FIGS. 5A-5E, in an embodiment, the housing 12 includes aplurality of rigid abutments (“housing abutments”) 260. Further, theactuator body 66 includes a plurality of rigid abutments (“actuatorabutments”) 276. As shown in FIGS. 5B-5E, the catheter assembly caninclude one or more indexing fingers 264. The indexing finger 264 canextend from a side wall of the safety assembly body 47 and can be angledtowards a proximal end. The indexing finger 264 can be configured toelastically deflect inward towards a central axis, and can be biased toan outward position as shown in FIGS. 5B-5E.

In an embodiment, the safety assembly body 47 includes a first indexingfinger 264A extending from a first side of the body 47 and a secondindexing finger 264B extending from a second side of the body 47. In anembodiment, the first and second sides are opposite each other, althoughother configurations are contemplated. The first indexing finger 264Aextends towards the actuator abutments 276 of the actuator body 66, andthe second indexing finger 264B extends toward the housing abutments 260of the housing 12.

In use, the button 68 of the actuator assembly 20 is initially in theretracted position as shown in FIG. 5A, and the user can slide thebutton 68 forward to a second, extended position. An abutment 276disposed toward the proximal end of the actuator body 66 engages thefirst indexing finger 264A disposed on an upper surface of the safetybody 47 and slides the catheter assembly forward a distancecorresponding to the distance of travel of the actuator button 68. Thehousing abutments 260 on the bottom wall 30 of the housing 12 arepositioned to complement the spacing and location of the actuatorabutments 276.

The forward movement of the safety body 47 toward the distal end 22 ofthe housing 12 causes the second indexing finger 264B to deflect until aproximal end thereof travels distally of a housing abutment 260. Theindexing finger 264B, which is biased outwardly, then engages thehousing abutment 260 to retain the body 47 in the advanced position andprevent the body 47 from sliding back toward the proximal end 24 of thehousing 12. The advancing movement of the body 47 advances the catheterforward over the fixed introducer needle 18.

The button 68 can then slide backward toward the retracted positionwhere the first indexing finger 264A deflects and slides over anadjacent actuator abutment 276 to engage a distally facing contact pointthereon. Thus completing a stage cycle that advances the catheterassembly by a step of the stepwise advancement. The button 68 can thenslide forward again to repeat the cycle where the first indexing finger264A and the second indexing finger 264B can engage consecutive actuatorabutments 276 and housing abutments 260 to advance the catheter 14 in astepwise manner.

In an embodiment, the button 68 can slide between the retracted positionand the extended position by manual manipulation by the user. In anembodiment, the catheter insertion device 10 can include a one or morebiasing members, e.g. a spring, to transition the button 68 and actuatorassembly between the retracted position and the extending position. Forexample, from the extended position to the retracted position, or fromthe retracted position to the extended position. Advantageously, thebiasing member can facilitate one-handed use of the catheter insertiondevice 10 by automatically resetting the actuator assembly to one of theretracted or extended positions, ready for manual manipulation of theactuator assembly 20 in a subsequent step.

In an embodiment, as shown in FIGS. 5B-5C, the indexing fingers 264 areintegrally molded with the safety body 47 to form a single structure. Inan embodiment, as shown in FIGS. 5C-5D, the indexing fingers 264 areformed as a separate structure from that of the safety body 47 andcoupled thereto. In an embodiment, the indexing finger 264 can be formedfrom the same material as the safety body 47 or from a differentmaterial. Exemplary materials include plastic, polymers, metals, alloys,or any suitably resilient material. As shown in FIGS. 5C-D, the indexingfingers 264 extend from a collar 266. The collar 266 can extend at leastpartially around a portion of the safety assembly body 47. In anembodiment, the collar 266 extends from a first side to a second side ofthe safety assembly body 47. In an embodiment the collar 266 encirclesthe safety assembly body 47 to surround the longitudinal axis of thebody 47. In an embodiment, the safety body 47 includes one or morerecesses configured to retain a portion of the collar 266, indexingfinger 264, or combinations thereof, to further secure the collar266/indexing fingers 264 thereto.

Advantageously, the catheter insertion device 10 including rigidactuator abutments 276, housing abutments 260, and flexible indexingfingers 264 requires less moving parts. This simplifies manufacture andassembly of the catheter insertion device 10 as well as providing a morerobust operation of the catheter insertion device 10. Further, byforming the indexing fingers as part of the safety body 47, themanufacture and assembly of the catheter insertion device 10 is furthersimplified. In the alternative that the indexing fingers are formed as aseparate structure, and optionally of a separate material, the amount ofspring forces or resistance to deflection, can be more accuratelydefined or modified. This allows the catheter insertion device 10 tobalance the actuator button 68 and catheter advancement forces.

As shown in FIGS. 6A-6D, in an embodiment, the catheter insertion device10 can include a combination of flexible housing tabs 60 and rigidactuator abutments 276. Other combinations are also contemplated forexample rigid housing abutments 260 and flexible actuator tabs 76. Asdescribed herein, the catheter insertion device 10 includes a housing 12and an actuator assembly 20 that includes a button 68 coupled to anactuator body 66. The actuator body 66 extends proximally, substantiallyto a proximal end of the housing 12, and includes a top wall 228, afirst side wall 226A, and a second side wall 226B. The top wall 228extends below the top wall 28 of the housing 12 and above the catheterassembly, which includes the catheter 14, catheter hub 16, and safetyassembly 46. The first side wall 226A, and the second side wall 226Bextend from the top wall 228, inside of the side walls 26 of the housing12, and outside of the catheter assembly. The top wall 228, first sidewall 226A, and second side wall 226B can create an inverse channelwithin which the catheter assembly can travel along a longitudinal axis.Optionally, the actuator body 66 can include a rounded or chamferedportion to fit snuggly within the interior cavity 50 of the housing 12.

In an embodiment, one of the first side wall 226A and the second sidewall 226B can include a plurality of notches 274 extending upwards froma lower edge of the side wall to define an abutment surface 276 on adistally facing surface of the notch 274. As shown, the notches 274define a substantially rectangular shape when viewed from a sideprofile, however it will be appreciated that notches 274 can also defineother shapes, such as triangular or semi-circular, and still remainwithin the scope of the present invention. In an embodiment, the sidewalls 226A, 226B can include a plurality of apertures disposed thereinto define the distally facing abutment surfaces 276.

FIG. 6B shows a close up view of the proximal end of the catheterinsertion device 10 shown in FIG. 6A. As shown, the safety assembly body47 includes a collar 266 that supports the first indexing finger 264Aand the second indexing finger 264B. In an embodiment, the indexingfingers 264A, 264B can also be formed as a single piece with the safetybody 47, as described herein. The collar 266 engages a portion of thesafety body 47 and supports the indexing fingers 264A, 264B in anoutwardly biased position. The first indexing finger 264A extends from afirst side portion of the safety body 47, and the second indexing finger264B extends from a second side portion of the safety body 47, oppositethe first side portion. The indexing fingers 264A, 264B are aligned withthe plurality of notches 274 so that a proximal tip of the indexingfingers 264 engage a distally facing abutment surface 276. The housing12 further includes a plurality of housing tabs 60 that engage a lowerportion of the safety body 47 to prevent proximal movement thereof, asdescribed herein.

In use, the catheter insertion device 10 includes an actuator button 68disposed in the retracted, starting position, for example, as shown inin FIG. 5A. A user can manipulate the actuator button 68 to move theactuator assembly 20 in a distal direction from the starting position,to an extended position (FIG. 6C). As shown in FIG. 6C, a proximalabutment surface 276, of the first side wall 226A engages the firstindexing fingers 264A, and a proximal abutment surface 276, e.g. a firstabutment surface 276 a, of the second side wall 226B engages the secondindexing finger 264B. Advancing the actuator assembly 20 to the extendedposition distally advances the catheter assembly. The catheter assemblyis advanced distally of a proximal tab 60. The tab 60 deflects downwardsto allow the catheter assembly to pass, before returning to theundeflected position to engage surface 64 on the safety assembly 46.This prevents proximal movement of the catheter assembly.

As shown in FIG. 6D, the actuator assembly 20 is then moved proximally,from the extended position to the retracted, starting position. As theactuator body 66 moves proximally, the first indexing finger 264A andthe second indexing finger 264B deflect to allow a portion of the sidewalls 226A, 226B to pass until an adjacent notch 274 aligns with theindexing fingers 264A, 264B allowing the indexing fingers to engage anadjacent abutment surface 276, e.g. a second abutment surface 276 b. Thecycle then repeats to advance the catheter assembly distally in astepwise manner.

Advantageously, embodiments including the actuator body 66 defining aninverse channel require relatively less moving parts to facilitatemanufacture and assembly. Further, the actuator body 66 provides achannel within which the catheter assembly can travel. The device 10also provides dual contact points between the actuator assembly 20 andthe safety assembly 46 that are disposed evenly about a central axis.These features provide an even application of force and prevents thecatheter assembly, or portions thereof, from pivoting relative to thelongitudinal axis during distal advancement. This prevents the indexingmechanism from jamming and provides a more robust operation.

In an embodiment, the catheter insertion device 10 can include a lockoutdevice. As described in more detail herein, the lockout device caninclude one of a button, collar, slider or tab. In general, the lockoutdevice can selectively restrict the stepwise advancement mechanism toinhibit the catheter insertion device 10 from advancing beyond aninitial stage, while still allowing some movement of the catheter 14relative to the needle 18. This allows a user to break any adhesionbetween the catheter 14 and the needle 18 that may have occurred duringmanufacture, prior to deployment of the catheter 14. The user can thenselectively unlock the lockout device to allow the catheter insertiondevice 10 to cycle through a first stage. Breaking the adhesion ensuresa smooth, uniform advancement through each stage of the stepwiseadvancement.

As shown in FIGS. 7A-7B, in an embodiment, the catheter insertion device10 includes a lockout button 240 that includes an actuator surface 242coupled with an engagement arm 244, and can transition between a lockedposition (e.g. FIG. 7A) and an unlocked position. The engagement surface244 includes a first, substantially circular aperture 246 defining afirst diameter (x) and a second, substantially circular aperture 248defining a second diameter (y). As shown in FIG. 7B, the first aperture246 and second aperture 248 can communicate to define a “keyhole” shapedaperture. As shown in FIG. 7A, the safety assembly body 47 includes acylindrical anchor portion 250, extending proximally therefrom, anddefining a substantially circular cross-section. The cross-section ofthe anchor 250 defines a diameter that is the same or less than thediameter (x) of the first aperture 246. The anchor 250 also includes aflange 252 extending radially from a proximal end of the anchor portion250. The flange 252 defines a diameter that is larger than the diameter(x) of the first aperture 246 but smaller than the diameter (y) of thesecond aperture 248.

As shown in FIG. 7A, the lockout button 240 is deployed in the lockedposition where the anchor 250 is disposed within the first aperture 246and the flange 252 abuts against the engagement arm 244. In thisposition the longitudinal movement of the safety assembly 46, as well ascatheter 14 and catheter hub 16, are restricted.

In an embodiment, the longitudinal movement of the safety assembly 46 isrestricted to a distance that is less than the longitudinal distancebetween adjacent housing abutments 260, adjacent actuator abutments 276,adjacent housing tabs 60, or adjacent actuator tabs 76. In anembodiment, the longitudinal movement of the safety assembly 46 isrestricted to a distance that is substantially half the longitudinaldistance between adjacent housing abutments 260, adjacent actuatorabutments 276, adjacent housing tabs 60, or adjacent actuator tabs 76.In an embodiment, the longitudinal movement of the safety assembly 46 isrestricted to a longitudinal distance of between 1 mm to 3 mm, howevergreater or lesser distances are also contemplated.

With the lockout button 240 in the locked position a user is able tomove the actuator assembly 20 so as to move the catheter 14 relative tothe needle 18, but is not able to move the catheter assembly 20 beyond afirst step of the stepwise advancement, i.e. not as far as the next tab60, or abutment 260. This movement breaks loose any adhesion between thecatheter 14 and the needle 18 that may have formed during manufacture,assembly, transport or storage. When the user is ready to advance thecatheter, the lockout button 240 can be transitioned to the unlockedposition, where the anchor 250 is disposed within the second aperture248 and the flange 252 can pass through the aperture 248. This allowsthe actuator assembly 20 to advance the catheter assembly in a stepwisemanner, as described herein. It will be appreciated that theconfiguration and location of the lockout button 240 and apertures 246,248 can vary from that shown in FIGS. 7A-7B without departing from thespirit of the invention. For example, the orientation of the apertures246, 248 can be reversed so that the unlocked position of the lockoutbutton 240 is an extended position and a locked position is a retractedposition. Similarly, the location of the button 240 can extend from alower, upper, or side surface of the housing 12.

Advantageously, the lockout button 240 allows the user to break looseany adhesion between the catheter 14 and the needle 18 that may haveformed during assembly, transport or storage. This loosens the movementbetween the catheter 14 and the needle 18 prior to use and ensures asmooth, uniform and controlled action when the catheter 14 is deployed.

As shown in FIGS. 8A-8D, in an embodiment, the catheter insertion device10 includes a lockout collar 280 that restricts movement of the actuatorbutton 68, the actuator assembly, and the catheter assembly engagedtherewith. The lockout collar 280 is disposed on an outer surface of thehousing 12 and encircles the housing 12 about the longitudinal axis. Inan embodiment, the collar 280 encircles a portion of the housing 12 suchthat it can be detached from the catheter insertion device 10 by slidingthe collar 280 perpendicular to the longitudinal axis. The housing 12includes one or more protrusions, for example a first protrusion 282 anda second protrusion 284, extending from an outer surface thereof. Thelockout collar 280 can slide relative to the first protrusion 282 and asecond protrusion 284 to transition between a locked position and anunlocked position.

As shown in FIGS. 8A-8B, the lockout collar 280 can be disposed in alocked position where the collar 280 is disposed between the firstprotrusion 282 and the actuator button 68 so as to cover at least aportion of the opening 32. In the locked position, the longitudinalmovement of the actuator assembly 20, and the catheter assembly engagedtherewith, is restricted.

In an embodiment, the longitudinal movement of the actuator assembly 20is restricted to a distance that is less than the length of the opening32. In an embodiment, the longitudinal movement of the actuator assembly20 is restricted to a distance that is substantially half of the lengthof the opening 32. In an embodiment, the longitudinal movement of theactuator assembly 20 is restricted to a distance that is less than thelongitudinal distance between adjacent housing abutments 260, adjacentactuator abutments 276, adjacent housing tabs 60, or adjacent actuatortabs 76. In an embodiment, the longitudinal movement of the actuatorassembly 20 is restricted to a distance that is substantially half ofthe longitudinal distance between adjacent housing abutments 260,adjacent actuator abutments 276, adjacent housing tabs 60, or adjacentactuator tabs 76. In an embodiment, the longitudinal movement of theactuator assembly 20 is restricted to a distance of between about 1 mmto about 3 mm, however greater or lesser distances are alsocontemplated.

With the lockout collar 280 in the locked position, a user is able tomove the actuator assembly 20 so as to move the catheter 14 relative tothe needle 18, but is not able to move the catheter assembly beyond afirst step of the stepwise advancement, i.e. not as far as the nexthousing tab 60, or housing abutment 260. This movement breaks loose anyadhesion between the catheter 14 and the needle 18 that may have formedduring assembly, transport or storage. When the user is ready to advancethe catheter 14, the lockout collar 280 can be removed, or slid to theunlocked position, i.e. between the first protrusion 282 and the secondprotrusion 284 where the collar 280 does not cover the opening 32. Thisallows the actuator assembly 20 to advance the catheter assembly in astepwise manner, as described herein.

In an embodiment, the first protrusion 282 is disposed at one of adistal end or a proximal end of the opening 32 and configured torestrict movement of the collar 280 relative to the housing along alongitudinal axis to maintain the lockout collar 280 in the lockedposition. When ready for use, the user can slide the lockout collar 280over the first protrusion 282 to the “unlocked” position. In anembodiment, the collar 280 further includes a skive 286 on an innersurface of the collar 280 to facilitate moving the lockout collar 280over the first protrusion 282.

The second protrusion 284 can be positioned a distance from the firstprotrusion 282 so that the lockout collar 280 can be receivedtherebetween. In an embodiment, the first protrusion 282 and the secondprotrusion 284 protrude a similar height from the outer surface of thehousing 12. Optionally, the lockout collar 280 can be slid past thesecond protrusion 284 and be removed from the catheter insertion device10. In an embodiment, the second protrusion 284 protrudes further fromthe outer surface of the housing 12 than the first protrusion 282, andprevents the lockout collar 280 from being removed from the catheterinsertion device 10. Optionally, the lockout collar 280 includes acontrasting color, tactile features, gripping features, alphanumericsymbols, icons, or combinations thereof, to distinguish the lockoutcollar 280 from that of the housing 12 and notify the user that thecatheter insertion device 10 is in the locked or unlocked position.

As shown in FIGS. 8A-8D, the lockout collar 280, first protrusion 282,and second protrusion 284 are disposed between the actuator button 68and a proximal end of the catheter insertion device 10 such that thecollar 280 is slid in a proximal direction to the “unlocked” position.It will be appreciated, however, that the orientation of the actuatorbutton 68, lockout collar 280, first protrusion 282, and secondprotrusion 284 can be disposed in other configurations without departingfrom the spirit of the invention. For example, the collar 280 can beslid in a distal direction to move from the locked position to theunlocked position and optionally be removed from the catheter insertiondevice 10.

As shown in FIGS. 9A-9C, in an embodiment, the catheter insertion device10 can include a lockout slider 270 that can transition between a lockedposition, to restrict the movement of the actuator button 68 (FIG. 9A),and an unlocked position to allow the actuator assembly to move alongthe elongate opening 32 (FIG. 9C). In an embodiment, the lockout slider270 can be slid perpendicular to the longitudinal axis, i.e. thedirection of travel of the actuator assembly 20, to engage notch 268.However, it will be appreciated that other orientations of slider 270and notch 268 are also contemplated.

A longitudinal width of the slider 270 can define a first width (a). Alongitudinal width of the notch 268 can define a second width (b). In anembodiment, the width of the slide (a) is less than a width of the notch(b). The notch 268 can engage the slider 270 to restrict the movement ofthe actuator assembly 20. As shown in FIG. 9A, the lockout slider 270 isdeployed in the locked position where the slider 270 engages notch 268.In this position the longitudinal movement of the safety actuatorassembly 20 and the catheter assembly engaged therewith, are restricted.

In an embodiment, the longitudinal movement of the actuator assembly 20is restricted to a distance that is less than the length of the opening32. In an embodiment, the longitudinal movement of the actuator assembly20 is restricted to a distance that is substantially half of the lengthof the opening 32. In an embodiment, the longitudinal movement of theactuator assembly 20 is restricted to a distance that is less than thelongitudinal distance between adjacent housing abutments 260, adjacentactuator abutments 276, adjacent housing tabs 60, or adjacent actuatortabs 76. In an embodiment, the longitudinal movement of the actuatorassembly 20 is restricted to a distance that is substantially half ofthe longitudinal distance between adjacent housing abutments 260,adjacent actuator abutments 276, adjacent housing tabs 60, or adjacentactuator tabs 76. In an embodiment, the longitudinal movement of theactuator assembly 20 is restricted to a distance of between about 1 mmto about 3 mm, however greater or lesser distances are alsocontemplated.

With the lockout slider 270 in the locked position a user is able tomove the actuator assembly 20 so as to move the catheter 14 relative tothe needle 18, but is not able to move the catheter assembly beyond afirst step of the stepwise advancement, i.e. not as far as the nexthousing tab 60, or housing abutment 260. This movement breaks loose anyadhesion between the catheter 14 and the needle 18 that may have formedduring assembly, transport or storage. When the user is ready to advancethe catheter, the lockout slider 270 can be moved to the unlockedposition, where the actuator assembly 20 can advance the catheterassembly in a stepwise manner, as described herein.

FIGS. 10A-10D show an embodiment of the catheter insertion device 10including a lockout tab 290. FIG. 10A shows a plan view of the catheterinsertion device 10 and FIG. 10B shows a cutaway side view of thecatheter insertion device 10 with the lockout tab 290 in the “locked”position, i.e. disposed within guide slot 77 of housing 12. To note, aproximal end 74 of the actuator body 66 includes a guide pin 75 that isreceived within slot 77 to stabilize the proximal end 74 of the actuatorbody 66. Further details of which can be found in WO 2018/170349, whichis incorporated by reference in its entirety herein.

FIG. 10C shows a cutaway plan view of the catheter insertion device 10and FIG. 10D shows a cutaway side view of the catheter insertion device10 with the lockout tab 290 in the “unlocked” position, i.e. removedfrom slot 77. In an embodiment, the catheter insertion device 10includes a first slot 77A disposed on a first of the housing 12 and asecond slot 77B disposed on a second side of the housing 12, oppositethe first side. In an embodiment, the lockout tab 290 can be disposedthrough either of the first slot 77A or the second slot 77B. In anembodiment, the lockout tab 290 can be disposed through both of thefirst and second slots 77A, 77B.

As shown in FIG. 10B, in the “locked” position, the lockout tab 290 isdisposed between a proximal end of the actuator assembly 20 and an innersurface of the housing 12, i.e. between the guide pin 75 and a proximaledge of the slot 77, to restrict movement of the actuator assembly 20,and catheter 14. The longitudinal width (t) of the lockout tab 290 canbe less than the longitudinal length of the slots 77A, 77B, and can bemodified to vary the amount of restriction imposed on the actuatorassembly 20.

In an embodiment, the longitudinal movement of the actuator assembly 20is restricted to a distance that is less than the longitudinal length ofthe first slot 77A or the second slot 77B. In an embodiment, thelongitudinal movement of the actuator assembly 20 is restricted to adistance that is substantially half of the longitudinal length of thefirst slot 77A or the second slot 77B. In an embodiment, thelongitudinal movement of the actuator assembly 20 is restricted to adistance that is less than the longitudinal distance between adjacenthousing abutments 260, adjacent actuator abutments 276, adjacent housingtabs 60, or adjacent actuator tabs 76. In an embodiment, thelongitudinal movement of the actuator assembly 20 is restricted to adistance that is substantially half of the longitudinal distance betweenadjacent housing abutments 260, adjacent actuator abutments 276,adjacent housing tabs 60, or adjacent actuator tabs 76. In anembodiment, the longitudinal movement of the actuator assembly 20 isrestricted to a distance of between about 1 mm to about 3 mm, howevergreater or lesser distances are also contemplated.

With the lockout button 240 in the locked position a user is able tomove the actuator assembly 20 so as to move the catheter 14 relative tothe needle 18, but is not able to move the catheter assembly beyond afirst step of the stepwise advancement, i.e. not as far as the next tab60, or abutment 260. This movement breaks loose any adhesion between thecatheter 14 and the needle 18 that may have formed during manufacture,assembly, transport or storage. When the user is ready to advance thecatheter, the lockout tab 290 can be removed. This allows the actuatorassembly 20 to advance the catheter assembly in a stepwise manner, asdescribed herein. Optionally, the lockout device, e.g. the lockout tab290, can include a contrasting color, tactile features, grippingfeatures, alphanumeric symbols, icons, or combinations thereof, todistinguish the lockout tab 290 from that of the housing 12 and notifythe user that the catheter insertion device 10 is in the locked orunlocked position.

While some particular embodiments have been disclosed herein, and whilethe particular embodiments have been disclosed in some detail, it is notthe intention for the particular embodiments to limit the scope of theconcepts provided herein. Additional adaptations and/or modificationscan appear to those of ordinary skill in the art, and, in broaderaspects, these adaptations and/or modifications are encompassed as well.Accordingly, departures may be made from the particular embodimentsdisclosed herein without departing from the scope of the conceptsprovided herein.

What is claimed is:
 1. A catheter placement device, comprising: ahousing; a needle extending from a distal end of the housing; a catheterassembly disposed coaxially over the needle, including a cathetersupported by a catheter hub, and a safety assembly including a firstindexing finger; and an actuator assembly configured to transitionlongitudinally between a first position and a second position, theactuator assembly comprising: an actuator button extending through anelongate opening in the housing; and an actuator body including aplurality of actuator abutments, wherein the first indexing fingerengages a first actuator abutment of the plurality of actuator abutmentsand the actuator assembly distally advances the catheter assembly in astepwise manner as the actuator assembly moves between the firstposition and the second position.
 2. The catheter placement deviceaccording to claim 1, further comprising a lockout device thattransitions between a locked position and an unlocked position, thelocked position allowing a movement of the catheter relative to theneedle and restricting distal advancement of the catheter assembly inthe stepwise manner.
 3. The catheter placement device according to claim2, wherein the movement of the catheter relative to the needle isrestricted to less than a longitudinal distance between the firstactuator abutment and a second actuator abutment, adjacent to the firstactuator abutment.
 4. The catheter placement device according to claim2, wherein the movement of the catheter relative to the needle isrestricted to less than half a longitudinal distance between the firstactuator abutment and a second actuator abutment, adjacent to the firstactuator abutment.
 5. The catheter placement device according to claim2, wherein the movement of the catheter relative to the needle isrestricted to a distance of between 1 mm to 3 mm.
 6. The catheterplacement device according to claim 2, wherein the lockout deviceincludes a lockout button including an engagement arm having a firstaperture defining a first diameter, and a second aperture defining asecond diameter, the second diameter being larger than the firstdiameter, the first aperture communicating with the second aperture todefine a keyhole shape that receives an anchor portion of the safetyassembly therethrough.
 7. The catheter placement device according toclaim 6, wherein the lockout button transitions between the lockedposition and an unlocked position, the anchor portion is disposed withinthe first aperture in the locked position and the second aperture in theunlocked position.
 8. The catheter placement device according to claim7, wherein the anchor portion includes a flange that extends radiallyfrom a proximal end of the anchor portion, the flange defining adiameter that is larger than the first diameter and smaller than thesecond diameter, the flange abuts against the engagement arm when thelockout button is in the locked position.
 9. The catheter placementdevice according to claim 2, wherein the lockout device includes alockout collar slidably engaged with an outer surface of the housing andtransitions longitudinally between the locked position and the unlockedposition.
 10. The catheter placement device according to claim 9,wherein the lockout collar encircles a longitudinal axis of the housing,the lockout collar covering a portion of the elongate opening in thelocked position to restrict movement of the actuator assembly.
 11. Thecatheter placement device according to claim 9, wherein the lockoutcollar is disposed between the actuator button and a first protrusion inthe locked position, and between the first protrusion and a secondprotrusion in the unlocked position.
 12. The catheter placement deviceaccording to claim 2, wherein the lockout device includes a lockoutslider disposed on the actuator button and slides perpendicular to alongitudinal axis to engage a notch, when in the locked position. 13.The catheter placement device according to claim 12, wherein alongitudinal width of the slider is less than a longitudinal width ofthe notch to allow movement of the actuator button in the lockedposition and restrict distal advancement of the catheter assembly in thestepwise manner.
 14. The catheter placement device according to claim12, wherein the lockout slider in the unlocked position aligns with theactuator button to disengage the notch and allow the actuator assemblyto move between the first position and the second position.
 15. Thecatheter placement device according to claim 2, wherein the lockoutdevice includes a lockout tab interposed between the actuator assemblyand the housing in the locked position, which restricts movement of theactuator assembly.
 16. The catheter placement device according to claim12, wherein the lockout tab extends through a slot in the housing, thetab defining a longitudinal width that is less than a longitudinallength of the slot.
 17. A method of inserting a catheter, comprising:providing a catheter insertion device, comprising: a housing; a needleextending from a distal end of the housing; an actuator assemblyincluding an actuator button and an actuator body; a catheter assemblydisposed coaxially over the needle, comprising: a catheter supported bya catheter hub; and a safety assembly; and a lockout devicetransitionable between a locked position and an unlocked position, thelocked position permitting movement of the catheter relative to theneedle and inhibiting advancement of the catheter in a stepwise manner;actuating the actuator button with the lockout device in the lockedposition to move the catheter relative to the needle; transitioning thelockout device from the locked position to the unlocked position;inserting the needle into a patient to access a vasculature thereof; andactuating the actuator button from a first position to a second positionto advance the catheter in the stepwise manner relative to the needle.18. The method according to claim 17, wherein the actuator body includesa plurality of actuator abutments, and the safety assembly includes anindexing finger, the indexing finger engaging an actuator abutment ofthe plurality of actuator abutments as the actuator button moves fromthe first position to the second position, and the indexing fingerdeflecting as the actuator button moves from the second position to thefirst position.
 19. A method of advancing a catheter over a needle,comprising: providing a catheter placement device, comprising: a housingincluding a plurality of housing tabs and a needle extending from adistal end thereof; a catheter assembly including a catheter disposedcoaxially over the needle and engaging a first housing tab of theplurality of housing tabs; an actuator assembly configured to movebetween a first position and a second position to advance the catheterassembly from the first housing tab to a second housing tab adjacent tothe first housing tab; and a lockout device transitionable between alocked position and an unlocked position, the locked positionrestricting movement of the catheter assembly between the first housingtab and the second housing tab, the unlocked position permittingmovement of the catheter assembly between the first housing tab and thesecond housing tab; actuating the actuator button with the lockoutdevice in the locked position to move the catheter relative to theneedle while preventing the catheter assembly from advancing from thefirst housing tab to the second housing tab; transitioning the lockoutdevice from the locked position to the unlocked position; inserting theneedle into a patient to access a vasculature thereof; and actuating theactuator button from the first position to the second position toadvance the catheter assembly from the first housing tab to the secondhousing tab.
 20. The method according to claim 19, wherein the lockoutdevice is one of a lockout button, a lockout collar, a lockout sliderand a lockout tab.
 21. The method according to claim 19, wherein thehousing includes a first hinged door and a second hinged door, eachdisposed at the distal end of the housing and configured to pivot to anopen position to release the catheter hub.